[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588746":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":72,"centralContacts":76,"locations":85,"responsibleParty":105,"collaborators":49,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":116,"minAge":117,"maxAge":49,"enrollmentInfo":118,"targetDuration":49,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":49,"overallStatus":88,"whyStopped":49,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Eli Lilly and Company","INDUSTRY",[8,15,22,26,32,39],{"label":9,"type":10,"description":11,"interventionNames":12},"LY4057996 Part A (Cohorts A1-A5)","EXPERIMENTAL","LY4057996 administered subcutaneously (SC) and\u002For intravenously (IV)",[13,14],"Drug: LY4057996 SC","Drug: LY4057996 IV",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo Part A (Cohort A1-A5)","PLACEBO_COMPARATOR","Placebo administered SC and\u002For IV",[20,21],"Drug: Placebo SC","Drug: Placebo IV",{"label":23,"type":10,"description":24,"interventionNames":25},"LY4057996 Part B","LY4057996 administered SC",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"LY4057996 Part C","LY4057996 and interventions of pre-study basal insulin and Lispro administered SC",[13,30,31],"Drug: Lispro SC","Drug: Pre-study basal insulin SC",{"label":33,"type":34,"description":35,"interventionNames":36},"Degludec Part A (Cohort A2-A5)","ACTIVE_COMPARATOR","Degludec administered SC and\u002For IV",[37,38],"Drug: Degludec SC","Drug: Degludec IV",{"label":40,"type":34,"description":41,"interventionNames":42},"Degludec Part B","Degludec administered SC",[37],[44,50,54,57,60,63,66,69],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","LY4057996 SC","Administered SC",[9,23,27],null,{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"LY4057996 IV","Administered IV",[9],{"type":45,"name":55,"description":47,"armGroupLabels":56,"otherNames":49},"Placebo SC",[16],{"type":45,"name":58,"description":52,"armGroupLabels":59,"otherNames":49},"Placebo IV",[16],{"type":45,"name":61,"description":47,"armGroupLabels":62,"otherNames":49},"Degludec SC",[33,40],{"type":45,"name":64,"description":47,"armGroupLabels":65,"otherNames":49},"Lispro SC",[27],{"type":45,"name":67,"description":52,"armGroupLabels":68,"otherNames":49},"Degludec IV",[33],{"type":45,"name":70,"description":47,"armGroupLabels":71,"otherNames":49},"Pre-study basal insulin SC",[27],[73],{"name":74,"affiliation":5,"role":75},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[77,82],{"name":78,"role":79,"phone":80,"phoneExt":49,"email":81},"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","CONTACT","1-317-615-4559","LillyTrials@Lilly.com",{"name":83,"role":79,"phone":49,"phoneExt":49,"email":84},"Physicians interested in becoming principal investigators please contact","clinical_inquiry_hub@lilly.com",[86],{"facility":87,"status":88,"city":89,"state":49,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Profil Institut für Stoffwechselforschung","RECRUITING","Neuss","41460","Germany","DE",{"type":94,"coordinates":95},"Point",[96,97],6.68504,51.19807,{"lat":97,"lon":96},[100,102],{"name":49,"role":79,"phone":101,"phoneExt":49,"email":49},"+49 (0) 2131 4018 180",{"name":103,"role":104,"phone":49,"phoneExt":49,"email":49},"Oliver Klein","PRINCIPAL_INVESTIGATOR",{"type":106,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100588746","phase-1-a-study-of-ly4057996-in-healthy-participants-and-participants-with-type-1-and-type-2-diabetes-100588746",false,"NCT06945406","A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes","A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes","YKAA","Inclusion Criteria:\n\nPart A for Healthy Participants:\n\n* Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment\n\nPart A for Type 2 Diabetes (T2DM) Participants:\n\n* Are participants with T2DM diagnosed greater than 1 year before enrollment,\n* On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)\n* Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening\n\nPart B\n\n* Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol\u002FL) or less or non-fasting C-peptide level of 0.30 nmol\u002FL or less at screening\n* HbA1c 6% to 8.5% inclusive at screening\n\nPart C\n\n* Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol\u002FL) or less or non-fasting C-peptide level of 0.30 nmol\u002FL or less at screening\n* HbA1c 6 to 8.5% inclusive at screening\n\nAll Parts\n\n* Have blood pressure of less than 140\u002F90 millimeters of mercury (mmHg) for healthy participants or 150\u002F90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)\n* No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants\n\nExclusion Criteria:\n\n* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening\n* Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening\n\nAll Parts\n\n* Cardiovascular: no significant history of cardiovascular disease (CVD)\n* Gastrointestinal: have gastroparesis or have undergone gastric surgery\n* Hepatic: have acute or chronic hepatitis",true,"ALL","18 Years",{"count":119,"type":120},124,"ESTIMATED","INTERVENTIONAL",[123],"PHASE1","The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it.\n\nThe study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.",[126,127],"Diabetes Mellitus, Type 1","Diabetes Mellitus, Type 2","2026-03-09",{"date":130,"type":131},"2026-03-11","ACTUAL",{"date":133,"type":131},"2025-05-16",{"date":135,"type":120},"2026-12",{"name":5,"class":6},1]